Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
NCT00275379
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC
- Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test
- Use of herbal supplements (except for a daily multivitamin/mineral supplement not
containing herbal components)
- History of cancer (other than resected cutaneous basal or squamous cell carcinoma or
in situ cervical cancer) with less than 5 years documentation of a disease-free state
- Vaginitis or vaginal infection within 1 month before randomization
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Peoria, Arizona
- Fresno, California
- Glendora, California
- San Diego, California
- Boulder, Colorado
- Hartford, Connecticut
- Hartford, Connecticut
- Middlebury, Connecticut
- New Britain, Connecticut
- New London, Connecticut
- Atlanta, Georgia
- Jeffersonville, Indiana
- Shreveport, Louisiana
- Owings Mills, Maryland
- Royal Oak, Michigan
- Troy, Michigan
- Utica, Michigan
- St. Louis, Missouri
- Omaha, Nebraska
- New Hyde Park, New York
- Rochester, New York
- Greensboro, North Carolina
- Cincinnati, Ohio
- Bethany, Oklahoma
- Pittsburgh, Pennsylvania
- Greer, South Carolina
- Houston, Texas
- Mountlake, Washington
- Spokane, Washington
- Mobile, Alabama
- Mobile, Alabama
- Glendale, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Tucson, Arizona
- Beverly Hills, California
- Fresno, California
- Glendora, California
- Long Beach, California
- Los Angeles, California
- Murrieta, California
- Murrieta, California
- Signal Hill, California
- Boulder, Colorado
- Longmont, Colorado
- Longmont, Colorado
- Farmington, Connecticut
- New Britain, Connecticut
- New Britain, Connecticut
- Stamford, Connecticut
- Stamford, Connecticut
- Dover, Delaware
- Dover, Delaware
- Boynton Beach, Florida
- Jacksonville, Florida
- Lake Worth, Florida
- Naples, Florida
- New Port Richey, Florida
- New Port Richey, Florida
- New Port Richey, Florida
- Ocala, Florida
- Ocala, Florida
- Ocala, Florida
- Pinellas Park, Florida
- Saint Petersburg, Florida
- Trinity, Florida
- West Palm Beach, Florida
- Alpharetta, Georgia
- Alpharetta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Decatur, Georgia
- Evansville, Indiana
- Jeffersonville, Indiana
- Newburgh, Indiana
- Noblesville, Indiana
- Noblesville, Indiana
- West Des Moines, Iowa
- West Des Moines, Iowa
- Shreveport, Louisiana
- Annapolis, Maryland
- Annapolis, Maryland
- Brighton, Massachusetts
- Fall River, Massachusetts
- Grand Rapids, Michigan
- Kalamazoo, Michigan
- Kalamazoo, Michigan
- Kalamazoo, Michigan
- Royal Oak, Michigan
- Troy, Michigan
- Edina, Minnesota
- Edina, Minnesota
- Southaven, Mississippi
- Lincoln, Nebraska
- Lincoln, Nebraska
- Albany, New York
- Kingston, New York
- Kingston, New York
- New York, New York
- Poughkeepsie, New York
- Poughkeepsie, New York
- Rochester, New York
- Rochester, New York
- Salisbury, North Carolina
- Salisbury, North Carolina
- Winston-Salem, North Carolina
- Cincinnati, Ohio
- Cofumbus, Ohio
- Columbus, Ohio
- Westerville, Ohio
- Oklahoma City, Oklahoma
- Tulsa, Oklahoma
- Tulsa, Oklahoma
- Allentown, Pennsylvania
- Bala-Cynwyd, Pennsylvania
- Philadelphia, Pennsylvania
- Greer, South Carolina
- Greer, South Carolina
- Bristol, Tennessee
- Bristol, Tennessee
- Knoxville, Tennessee
- Knoxville, Tennessee
- Knoxville, Tennessee
- Memphis, Tennessee
- Memphis, Tennessee
- Memphis, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Murray, Utah
- Murray, Utah
- Salt Lake City, Utah
- Salt Lake City, Utah
- Salt Lake City, Utah
- Mountlake Terrace, Washington
- Mountlake Terrace, Washington
- Seattle, Washington
- Brussel,
- Edegem,
- Gent,
- Leuven,
- Abbotsford, British Columbia
- Barrie, Ontario
- Kingston, Ontario
- Kingston, Ontario
- Kitchener, Ontario
- Thunder Bay, Ontario
- Toronto, Ontario
- Sherbrooke, Quebec
- Kouvola,
- Shatin, NEW Territories
- Shatin,
- Fukuoka-shi, Fukuoka
- Nakagyo-ku, Kyoto-shi, Kyoto
- Arakawa-ku, Tokyo
- Bunkyo-ku, Tokyo
- Songpa-gu, Seoul
- Seoul,
- Seoul,
- Seoul,
- Bialystok,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Bucuresti, Sector 4
- Bucuresti,
- Pantelimon,
- Moscow,
- Moscow,
- Saint-Petersburg,
- St. Petersburg,
- St. Petersburg,
- Martin,
- Martin,
- Presov,
- Majadahonda, Madrid
- Barcelona,
- Barcelona,
- Goteborg,
- Malmo,
- Malmo,
- Koahsiung Hsien,
- Taichung City,
- Taipei,
- Taipei,
- Glendora, California
- Redding, California
- San Diego, California
- Aventura, Florida
- Kansas City, Kansas
- Jackson, Michigan
- Springfield, Oregon
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Houston, Texas
- Temple, Texas
- Mountlake Terrace, Washington
- Baden,
- Homburg/Saar,
- Munster,
Descriptive Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis | |||||||||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis | |||||||||
Brief Summary | This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered ERB-041 in subjects with active IC. The primary objectives of this study will be to investigate ERB-041's activity on levels of urinary APF, explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to evaluate the safety of ERB-041 in women with active IC. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||||||||
Condition ICMJE | Cystitis, Interstitial | |||||||||
Intervention ICMJE | Drug: ERB-041 | |||||||||
Study Arms ICMJE | Not Provided | |||||||||
Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
Recruitment Information | ||||||||||
Recruitment Status ICMJE | Withdrawn | |||||||||
Actual Enrollment ICMJE | 0 | |||||||||
Original Enrollment ICMJE | 60 | |||||||||
Study Completion Date ICMJE | Not Provided | |||||||||
Primary Completion Date | Not Provided | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||
Sex/Gender ICMJE |
| |||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Austria, Germany, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00275379 | |||||||||
Other Study ID Numbers ICMJE | 3142A4-109 B2381036 ( Other Identifier: Pfizer ) | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
| |||||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
Verification Date | September 2020 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |